Clinical Evaluation of Primary Sampling Scatter Correction for Chest Tomosynthesis

NCT04076696 | Completed Results DMC FDA Device

• 3 other identifiers: LCCC182218-11441R21CA216780-01A1
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

This is a study that will evaluate the utility of a scatter reduction technique in reducing dose and increasing the sensitivity of stationary digital chest tomosynthesis (s-DCT) in the detection of lung lesions.

Conditions

Pulmonary Nodule, Solitary; Pulmonary Nodule, Multiple

Keywords

Chest; Lung; Tomography; Scatter

Outcome Measures

Primary Outcomes (1)

• Reader Confidence in s-DCT Images Compared to Conventional CT (Units on a Scale)

  Readers will rate their confidence in images from the experimental modality (sDCT with scatter correction) as compared to the conventional scan (chest CT with x-ray) on a 7 point Likert scale (-3 to 3) based on ability to identify lesion(s) present comparing each modality. A value of -3 is significantly less confident in the s-DCT representation 0 is the same confidence in modalities, and 3 is significantly more confident in the s-DCT representation compared to the conventional. Each individual will have a single value per reader. Two readers compared each scan. The overall reader preference between modalities was calculated by determining the mean value.

  Baseline

Secondary Outcomes (1)

• Sensitivity of s-DCT Images (Percentage of Positive Scans)

  Baseline

Study Arms (1)

Scatter corrected s-DCT

EXPERIMENTAL

The study scan, s-DCT and correction scan, will be performed within two weeks of the patient's clinical evaluations by chest CT and x-ray. The study scan may be done within 2 weeks prior or two weeks following standard of care imaging. There cannot be any intervening therapies or procedures (i.e. biopsy or excision of lesions) done in between the standard of care (SOC) imaging and the s-DCT. All patients will have a breath held s-DCT scan in an anterior-posterior direction.

Device: Scatter corrected s-DCT

Interventions

Scatter corrected s-DCT DEVICE

All patients will have a breath held s-DCT scan in an anterior-posterior direction

Scatter corrected s-DCT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with known lung lesion(s)
• Patients having undergone a chest CT
• Patients 18 years of age and older
• Patients able to provide informed consent

You may not qualify if:

• Patients who may not fit on a 35 x 35 detector (BMI \> 35)
• Planned procedures or therapies during study (in between SOC scans and study scan on s-DCT) (biopsy or removal of lung lesion)
• Any woman who is pregnant, has reason to believe she is pregnant, or is lactating

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Solitary Pulmonary Nodule; Multiple Pulmonary Nodules

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms

Results Point of Contact

• Title: Director, Clinical Research, Department of Radiology
• Organization: University of North Carolina at Chapel Hill

rad_research@med.unc.edu

919-966-4997

Study Officials

• Ertan Pamuklar, MD

  UNC Hospitals

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2019
• First Posted: September 3, 2019
• Study Start: August 26, 2020
• Primary Completion: August 26, 2021
• Study Completion: August 26, 2021
• Last Updated: August 8, 2022
• Results First Posted: August 8, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 9 to 36 months following publication
• Access Criteria: The investigator who proposes to use the data has approval from an IRB, IEC, or REB, as applicable, and an executed data use/sharing agreement with UNC.

Locations

US (1)